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New pill could stop swelling attacks in hereditary angioedema

NCT ID NCT06343779

Disease control Sponsor: Pharvaris Netherlands B.V. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an oral medication called deucrictibant for quickly treating attacks of hereditary angioedema (HAE), a condition causing sudden, painful swelling. The trial involved 134 adolescents and adults with HAE types 1, 2, or 3. Participants took either the drug or a placebo at the start of an attack to see if it shortened time to symptom relief. The goal is to offer a convenient, on-demand pill option for managing HAE attacks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
deucrictibant (oral soft capsule)
What this could lead to
If successful, this could provide a convenient, on-demand oral treatment to quickly relieve swelling attacks in people with hereditary angioedema.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The drug may not prove significantly better than placebo, and side effects are possible. It is not a cure—patients would still need ongoing management.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

134 people

The number who actually took part.

Started

Feb 2024

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Provision of written informed consent/assent. 2. Male or female, aged ≥12 to ≤75 years at the time of providing written informed consent/assent. 3. Diagnosis of HAE-1/2/3. 4. History of at least 2 HAE attacks in the last 3 months before screening. 5. Experience with using standard-of-care treatment to effectively manage on-demand treatment for HAE attacks. 6. Participants on long-term prophylactic therapy with plasma-derived C1-INH (danazol, anti-fibrinolytics, berotralstat, or lanadelumab) must be on a stable dose and regimen and intend to remain on the same dose for 6 months before screening and the duration of the study. OR, Participant has stopped using plasma-derived C1-INH (danazol, anti-fibrinolytics, berotralstat) at least 2 weeks or lanadelumab at least 10 weeks before screening. 7. Capable of recording, without assistance, electronic HAE diary and ePRO data using an electronic device. 8. For adolescent participants aged ≥12 and \<18 years of age: body weight ≥40 kg. 9. Female participants of childbearing potential must agree to the protocol specified pregnancy testing and contraception methods. Exclusion Criteria: 1. Any female who is pregnant, plans to become pregnant, or is breastfeeding. 2. Any diagnosis of angioedema other than HAE. 3. Any clinically significant comorbidity or systemic dysfunction that would interfere with the participant's safety or ability to participate in the study. 4. Use of attenuated androgens for short-term prophylaxis within 2 weeks before screening. 5. Abnormal hepatic function. 6. Abnormal renal function (eGFR \<60 ml/min/1.73 m2). 7. History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse. 8. Has received prior on-demand HAE treatment with deucrictibant. 9. Currently participating in any other investigational drug study or receiving other investigational treatment within the last 30 days, or within 5 half-lives (whichever is longer) of the time of randomization. 10. Prior gene therapy for any indication at any time. 11. Use of concomitant medications with systemic absorption that are strong inhibitors of CYP3A4 or strong inducers of CYP3A4 within the last 30 days, or within 5 half-lives (whichever is longer) of the time of randomization. 12. Known hypersensitivity to study drug or any of the excipients of study drug.

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Conditions

The condition(s) this trial relates to.

C1 inhibitor deficiency hereditary angioedema hereditary angioedema type 1 hereditary angioedema type 2 hereditary angioedema type 3 Hereditary Angioedema Types I and II hereditary angioedema with C1Inh deficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

C1 esterase inhibitor [C1-inh] deficiency C1 esterase inhibitor deficiency C1 esterase inhibitor, deficiency of C1 inhibitor deficiency Hereditary angioedema Hereditary angioedema - type 1 Hereditary angioedema - type 2 Hereditary angioedema - type 3 Hereditary angioedema attack Hereditary angioedema type I Hereditary angioedema type II Hereditary angioedema type III Hereditary angioedema types I and II Hereditary angioedema with C1 esterase inhibitor deficiency

Contacts and locations

Locations

  • Study Site

    Birmingham, Alabama, 35209, United States

  • Study Site

    Paradise Valley, Arizona, 85258, United States

  • Study Site

    Little Rock, Arkansas, 72205, United States

  • Study Site

    San Diego, California, 92122, United States

  • Study Site

    Santa Monica, California, 90404, United States

  • Study Site

    Walnut Creek, California, 94598, United States

  • Study Site

    Colorado Springs, Colorado, 80907-6231, United States

  • Study Site

    Chevy Chase, Maryland, 20815, United States

  • Study Site

    Boston, Massachusetts, 02115, United States

  • Study Site

    Detroit, Michigan, 48202, United States

  • Study Site

    St Louis, Missouri, 63141, United States

  • Study Site

    Hershey, Pennsylvania, 17033, United States

  • Study Site

    Dallas, Texas, 75231, United States

  • Study Site

    Buenos Aires, B1629AHJ, Argentina

  • Study Site

    Salta, 4400, Argentina

  • Study Site

    Campbelltown, New South Wales, 2560, Australia

  • Study Site

    Box Hill, 3128, Australia

  • Study Site

    Graz, 8036, Austria

  • Study Site

    Linz, 4021, Austria

  • Study Site

    Vienna, 1090, Austria

  • Study Site

    Paraná, 80810-100, Brazil

  • Study Site

    Ribeirão Preto, 14048-900, Brazil

  • Study Site

    Salvador, 41950-640, Brazil

  • Study Site

    Santo André, 09060-870, Brazil

  • Study Site

    São Paulo, 05403-000, Brazil

  • Study Site

    Sofia, 1431, Bulgaria

  • Study Site

    Sofia, 1680, Bulgaria

  • Study Site

    Edmonton, Alberta, T6G 1Z1, Canada

  • Study Site

    Bogotá, 00, Colombia

  • Study Site

    Bogotá, 111221, Colombia

  • Study Site

    Bogotá, 111711, Colombia

  • Study Site

    Medellín, 050021, Colombia

  • Study Site

    Brno, 602 00, Czechia

  • Study Site

    Lille, 59037, France

  • Study Site

    Paris, 75571, France

  • Study Site

    Berlin, 12203, Germany

  • Study Site

    Frankfurt am Main, 60590, Germany

  • Study Site

    Frankfurt am Main, 60596, Germany

  • Study Site

    Lübeck, 23538, Germany

  • Study Site

    Hong Kong, Hong Kong

  • Study Site

    Budapest, 1088, Hungary

  • Study Site

    Dublin, D08 A978, Ireland

  • Study Site

    Catania, 95124, Italy

  • Study Site

    Milan, 20138, Italy

  • Study Site

    Milan, 20097, Italy

  • Study Site

    Padova, 35128, Italy

  • Study Site

    Palermo, 90146, Italy

  • Study Site

    Roma, 00133, Italy

  • Study Site

    Chiba, 260-8677, Japan

  • Study Site

    Hiroshima, 730-8518, Japan

  • Study Site

    Kanagawa, 216-8511, Japan

  • Study Site

    Osaka, 569-8686, Japan

  • Study Site

    Tokyo, 113-8431, Japan

  • Study Site

    Amsterdam, 1105 AZ, Netherlands

  • Study Site

    Skopje, 1000, North Macedonia

  • Study Site

    Krakow, 31-503, Poland

  • Study Site

    San Juan, 00918, Puerto Rico

  • Study Site

    San Juan, 00927, Puerto Rico

  • Study Site

    Sângeorgiu de Mureş, 547530, Romania

  • Study Site

    Riyadh, 11471, Saudi Arabia

  • Study Site

    Singapore, 308433, Singapore

  • Study Site

    Cape Town, 7700, South Africa

  • Study Site

    Daegu, 41944, South Korea

  • Study Site

    Seoul, 03080, South Korea

  • Study Site

    Barcelona, 08035, Spain

  • Study Site

    Barcelona, 08907, Spain

  • Study Site

    Lund, 22185, Sweden

  • Study Site

    Ankara, 06203, Turkey (Türkiye)

  • Study Site

    Istanbul, 34093, Turkey (Türkiye)

  • Study Site

    Izmir, 35100, Turkey (Türkiye)

  • Study Site

    Bristol, BS10 5NB, United Kingdom

  • Study Site

    Camberley, GU16 7UJ, United Kingdom

  • Study Site

    Cambridge, CB2 0QQ, United Kingdom

  • Study Site

    Leeds, LS9 7TF, United Kingdom

  • Study Site

    London, E1 2ES, United Kingdom

  • Study Site

    Plymouth, PL6 8DH, United Kingdom

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